NCT03331536

Skeletal Health in Bariatric Surgery Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The investigators propose a prospective cohort trial that will help to understand the impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in pre- and post-menopausal female bariatric patients.

Detailed description

While highly effective both RYGB and SG may lead to increased bone resorption, decreased bone mass, and increased risk of some fractures. Very few studies have compared the effects of the RYGB and the SG on changes skeletal health and findings have been inconsistent. Furthermore, few studies have investigated the short- or long-term consequences of bariatric surgery on bone mineral density in pre- and post-menopausal women. To what extent and how bariatric surgery impacts the skeleton largely remains undetermined. Because estrogen is protective against osteoporosis and fractures, the majority of fractures occur in postmenopausal women. It is important that women have higher rates of obesity (38.3%) compared to men (34.3%) and that ≥67% of bariatric patients are women. Therefore, women may be at a significantly increased risk of developing osteoporosis. These data may help establish clinical guidelines to assess, maintain, and promote skeletal health in the preoperative and postoperative care of bariatric patients; and it may help to determine the appropriate bariatric procedure for women at risk of osteoporosis and fractures.

Conditions

• Bariatric Surgery
• Osteoporosis
• Fractures, Bone
• Roux En-Y Gastric Bypass
• Sleeve Gastrectomy
• Menopause
• Premenopause

Interventions

Type	Name	Description
PROCEDURE	Roux en Y Gastric Bypass Pre-menopausal	The investigator aims to determine changes in skeletal health after Roux en Y Gastric Bypass in pre-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.
PROCEDURE	Roux en Y Gastric Bypass Post-menopausal	The investigator aims to determine changes in skeletal health after Roux en Y Gastric Bypass in post-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.
PROCEDURE	Sleeve Gastrectomy Pre-menopausal	The investigator aims to determine changes in skeletal health after Sleeve Gastrectomy in pre-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.
PROCEDURE	Sleeve Gastrectomy Post-menopausal	The investigator aims to determine changes in skeletal health after Sleeve Gastrectomy in post-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.

Timeline

• Start date: 2018-03-22
• Primary completion: 2020-08-02
• Completion: 2020-08-02
• First posted: 2017-11-06
• Last updated: 2020-08-18

Locations

1 site across 1 country: United States